Trial Exploring Combined Neoadjuvant Therapy With Pembrolizumab/Lenvatinib + Adjuvant Pembrolizumab in Pat. With NSCLC

Recruiting Phase 2 Interventional Study
Non Small Cell Lung Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
33 (estimated)
Sponsor
Medical University Innsbruck · Other
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About This Trial

The primary aim of this single arm, phase II study is to determine the efficacy of the combination therapy Pembrolizumab/Lenvatinib regarding the rate of major pathological response (MPR-Rate). The investigators expect to improve the MPR-Rate of 20% in Anti-PD1/-PD-L1 monotherapy (observed in recent trials) to a MPR-Rate of 40% with the combination therapy Pembrolizumab/Lenvatinib.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male/female participants ≥18 years of age 2. Histologically confirmed primary diagnosis of resectable NSCLC, stages IA3-IIIA (max. single station N2). 3. Measurable disease based on RECIST 1.1. 4. Male participants must agree to use a contraception as detailed in Appendix 3 o…
Contacts

KKS Innsbruck

+43 0512 09003

kks-regulatory@i-med.ac.at

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